Upcoming Webinar:
ASCPT Members-Only Webinar Presented by the Special Populations (SPO) Community
Title:
Ethnic Diversity and Drug Response: Drug Development Consequences
Date and Time: Thursday, January 21, 2021, 3:30 pm ET
Speaker: Annette Gross, PhD
Moderators: Elimika Pfuma Fletcher, PharmD, PhD, and Pooja Manchandani, PhD
Description: This presentation will provide an overview of inter-ethnic differences in drug response, inclusive of the intrinsic and extrinsic factors which can be associated with population differences in pharmacokinetics, pharmacodynamics, efficacy, and safety. Drug development considerations will be discussed in relation to potential inter-ethnic differences in drug response including relevant regulatory guidelines (e.g., ICH E5, ICH E17) and assessment of ethnic sensitivity, US Food & Drug Administration Clinical Trial Diversity initiative, requirements for clinical trial data in specific countries / ethnic groups, and implications for drug development strategies and design of clinical studies (e.g., Multiregional Clinical Trials, Bridging Studies).
Registration Link: https://us02web.zoom.us/webinar/register/3116098729528/WN_YVZtagb4TRexjOoRG3cxNg
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